Catalog Number

NGS-NC-04

Brand Name

SmartFlow

Version/Model Number

NGS-NC-04

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Safe

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K102101

Product Code

HCD

Product Code Name

Cannula, Ventricular

Public Device Record Key

7b0e184b-8dce-4cf2-abc9-fdde7b49ddab

Public Version Date

June 22, 2022

Public Version Number

3

DI Record Publish Date

January 22, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-